A Mechanistic Study of MAR001 in Adults With Elevated Tri... | NCT07199309

Studies
A Mechanistic Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol

NCT07199309

Sponsor

Marea Therapeutics

Status

Recruiting

Last Update Posted

Nov 6, 2025Actual

Enrollment

30Estimated

Phase

Phase 2

Conditions

Hypertriglyceridemia

Interventions

MAR001
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 26, 2025Actual

Primary Completion Date

Jul 2026Estimated

Completion Date

Nov 2026Estimated

First Submitted Date

Sep 22, 2025

First Submission Date that Met QC Criteria

Sep 22, 2025

First Posted Date

Sep 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2025

Last Update Posted Date

Nov 6, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of the study is to determine the effect of MAR001 as compared to placebo on levels of the triglycerides (TG) in the postprandial state in adults with elevated TG.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MAR001 Dose	Experimental	Subcutaneous Injection	Drug: MAR001
Matching Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MAR001	Drug	Subcutaneous Injection	MAR001 Dose
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in TG area under the curve after a mixed meal		12 weeks
Change from baseline in peak plasma TG concentration after a mixed meal		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in RC area under the curve after a mixed meal		12 weeks
Change from baseline in peak plasma RC concentration after a mixed meal		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willingness to provide informed consent and comply with the intervention and all study assessments
Two fasting TG collected at two separate, consecutive visits at least 7 days apart during the Screening period
HbA1c ≥ 5.7% and ≤ 8.5%
Stable diet for a minimum of 3 months prior to screening and with no plans to change diet through duration of study
Stable drug regimen (appropriate if relevant) prior to screening visit and no planned changes during screening or trial participation

Exclusion Criteria:

Acute or chronic liver disease
Diabetes medications (other than metformin)
History of type 1 diabetes mellitus or history of diabetic ketoacidosis
Newly diagnosed T2DM
Participants with known active hepatitis A, B, or C
Participants who are known to have uncontrolled human immunodeficiency virus (HIV) infection
Uncontrolled hypothyroidism
Any condition that prevents the participant from complying with study procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrew Lane	Contact	415-766-3610		MAR-104-info@mareatx.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marea Site 301	Recruiting	Chula Vista	California	91911	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015228	Hypertriglyceridemia

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided